Prostate CancerNCT01990521
Prostate Screening Study Using MRI in BRCA Carriers
A study testing MS3TMRI / TRUS Guided Biopsy in people with Prostate Cancer, run by Toronto Sunnybrook Regional Cancer Centre at 1 site in Canada.
Trial summary
Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population. Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population. Read more about this study
- Who is it for?
- Ages 50 years and older, men only
- Conditions the study is for
- Prostate Cancer
- What is being tested?
- MS3TMRI / TRUS Guided Biopsy
- Type of treatment
- Medical device, Surgery or procedure
- Could I receive a placebo?
- No, everyone receives an active treatment
- How many people
- 60 participants
- Where
- 1 siteCanada
- Study dates
- Jan 2014to Sep 2026
- Phase
- Interventional
- Are there results?
- Not yet: the study is under way
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 50 years and older
- Men only
- No healthy volunteers
- Adult, Older adult
Who may be able to join
- Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center.
- Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation.
- Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI.
- Be 50 years of age or older.
Who cannot join
- Claustrophobia
- Contraindication to MRI
- Contraindication to receiving low molecular weight MRI contrast agent
- Previously diagnosed with prostate cancer
Trial locations and contacts
1 site in 1 country.
About this study
Official title: Screening Male BRCA Mutation Carriers: Effectiveness of Multispectral 3T Magnetic Resonance Imaging
Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population.
Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population.
This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease.
Read the detailed description
To determine the value of using Multispectral 3T MRI (MS3TMRI) for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status, with no prior prostate cancer diagnosis, independent of baseline PSA levels.
- Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels.
- To evaluate the accuracy of tumor targeting based on MRI and ultrasound (US) tumor co-localization. To evaluate the sensitivity, specificity, PPV, NPV, and accuracy of an automated computer aided diagnosis method (CAD) applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer.
- Conditions
- Prostate Cancer
- Being tested
- MS3TMRI / TRUS Guided Biopsy
- Medical subject headings
- Prostatic Neoplasms
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
MS3TMRI / TRUS Guided BiopsyProcedure or surgery
Patients would undergo MS3TMRI and then have a transrectal ultrasound (TRUS) biopsy performed within one month after the MRI. The initial cores would be obtained using TRUS without MRI information (TRUSBx). During the same biopsy session, the MS3TMRI information would be given to the physician performing the biopsy and additional cores specifically targeted to suspicious areas would be performed (MS3TMRI-TRUSBx).
MS3TMRI / TRUS Guided BiopsyDevice
Also called Multispectral 3T MRI, Transrectal Ultrasound
Multispectral 3T MRI (MS3TMRI) is a device that uses a 3T MRI system without an endorectal receiver coil and with a surface phased array coil. 3T MRI in addition to established computer aided diagnosis (CAD) has been used to perform guided biopsies in an active surveillance population and demonstrated a positive predictive value and negative predictive value of 83% and 81%.
A recently completed a study looking at repeat prostate biopsies in men followed on an active surveillance population at Sunnybrook has shown that the PPV of MS3TMRI guided biopsy to be 85%, while the negative predictive value was 100% (Haider, Vesprini and Milot, unpublished).
| Study group | Role | What they receive |
|---|---|---|
| MS3TMRI / TRUS Guided Biopsy | Experimental | Not described Receives: Procedure: MS3TMRI / TRUS Guided Biopsy; Device: MS3TMRI / TRUS Guided Biopsy |
What is being measured
The primary outcome is the main question the study is designed to answer.
Prostate MRI in BRCA carriers
Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer
Measured: 2 years (January 2016)
Secondary outcomes (1)
Prostate cancer in BRCA carriers
Prevalence of any prostate cancer compared to actionable cancer in men with a BRCA1 or BRCA2 mutation independent of serum PSA value.
Measured: 2 years January 2016
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted21 Nov 2013 (estimated)
- Study startJan 2014
- Primary completionSep 2025
- Study completionSep 2026 (estimated)
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Prostate CancerStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Interventional
- Phase
- Phase N/A
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Enrolment
- 60 participants (estimated)
Sponsor and investigators
- Lead sponsor
- Toronto Sunnybrook Regional Cancer Centre
- Sponsor type
- University, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Women's College Hospital
- Responsible party
- Principal investigator, Danny Vesprini, MD, MSc, FRCPC, Toronto Sunnybrook Regional Cancer Centre
- Investigators
- Danny J Vesprini, MD, MSc, FRCPC, Principal investigator, Sunnybrook Health Sciences Centre
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT01990521
- Sponsor's protocol ID
- 500-2013
- Status last verified
- Sep 2025
- First submitted
- 15 Nov 2013
- Last updated
- 9 Sep 2025
- Results posted
- No
- Data monitoring committee
- No
Study at a glance
From the registry record, last updated by the sponsor on 9 Sep 2025. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- Screening Male BRCA Mutation Carriers: Effectiveness of Multispectral 3T Magnetic Resonance Imaging
- ClinicalTrials.gov ID
- NCT01990521
- Acronym / sponsor ID
- 500-2013
- Conditions
- Prostate Cancer
- Study type
- Interventional
- Recruitment status
- Active, not recruiting
- Enrolment
- 60 participants (estimated)
- Lead sponsor
- Toronto Sunnybrook Regional Cancer CentreUniversity, hospital or other
- Collaborators
- Sunnybrook Health Sciences Centre, Women's College Hospital
- Study start
- Jan 2014 (actual)
- Primary completion
- Sep 2025 (actual)
- Study completion
- Sep 2026 (estimated)
- First posted
- 21 Nov 2013 (estimated)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
Men with a BRCA1 or BRCA2 mutation are at increased risk for early onset, aggressive prostate cancer compared to men in the general population.
Standard of care screening for men with a BRCA mutation includes PSA testing and digital rectal examination (DRE), the same as with men in the general population.
This study is being done to assess whether there is value in using MRI as a screening tool to detect prostate cancer at an earlier stage than may otherwise be detected using standard of care screening (PSA, DRE). It is unclear whether MRI has utility as a screening tool in this specific population at high risk for aggressive disease.
Detailed description
To determine the value of using Multispectral 3T MRI (MS3TMRI) for prostate cancer screening in men with a high risk of developing early onset aggressive prostate cancer given known BRCA1 or BRCA2 mutation carrier status, with no prior prostate cancer diagnosis, independent of baseline PSA levels.
- Determine the prevalence of prostate cancer in BRCA1 and BRCA2 mutation carriers independent of baseline PSA levels.
- To evaluate the accuracy of tumor targeting based on MRI and ultrasound (US) tumor co-localization. To evaluate the sensitivity, specificity, PPV, NPV, and accuracy of an automated computer aided diagnosis method (CAD) applied to MS3TMRI in the prediction of zonal biopsy results for the presence or absence of a significant cancer.
Study design
- Primary purpose
- Treatment
- Allocation
- Not applicable
- Intervention model
- Single group
- Masking
- None (open label)
- Number of arms
- 1
| Arm | Type | Receives |
|---|---|---|
| MS3TMRI / TRUS Guided Biopsy | Experimental | Procedure: MS3TMRI / TRUS Guided Biopsy, Device: MS3TMRI / TRUS Guided Biopsy |
Who may qualify
- Ages
- 50 years and older
- Sex
- Male only
- Healthy volunteers
- Not accepted
- Age groups
- Adult, Older adult
Key inclusion criteria (4 listed)
- Enrolled in the Male Hereditary Cancer Research Program at Sunnybrook Health Sciences Center.
- Have positive genetic testing for a pathogenic BRCA1 or BRCA2 mutation.
- Clinically eligible for and willing to undergo ultrasound biopsy within 4 weeks after the MRI.
- Be 50 years of age or older.
Key exclusion criteria (4 listed)
- Claustrophobia
- Contraindication to MRI
- Contraindication to receiving low molecular weight MRI contrast agent
- Previously diagnosed with prostate cancer
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| MS3TMRI / TRUS Guided BiopsyPatients would undergo MS3TMRI and then have a transrectal ultrasound (TRUS) biopsy performed within one month after the MRI. The initial cores would be obtained using TRUS without MRI information (TRUSBx). During the same biopsy session, the MS3TMRI information would be given to the physician performing the biopsy and additional cores specifically targeted to suspicious areas would be performed (MS3TMRI-TRUSBx). | Procedure or surgery | MS3TMRI / TRUS Guided Biopsy |
| MS3TMRI / TRUS Guided BiopsyAlso: Multispectral 3T MRI, Transrectal UltrasoundMultispectral 3T MRI (MS3TMRI) is a device that uses a 3T MRI system without an endorectal receiver coil and with a surface phased array coil. 3T MRI in addition to established computer aided diagnosis (CAD) has been used to perform guided biopsies in an active surveillance population and demonstrated a positive predictive value and negative predictive value of 83% and 81%. A recently completed a study looking at repeat prostate biopsies in men followed on an active surveillance population at Sunnybrook has shown that the PPV of MS3TMRI guided biopsy to be 85%, while the negative predictive value was 100% (Haider, Vesprini and Milot, unpublished). | Device | MS3TMRI / TRUS Guided Biopsy |
Primary outcome
Prostate MRI in BRCA carriers
Time frame: 2 years (January 2016)
Measure of prostate MRI to determine the PPV of MRI for detection of actionable prostate cancer
1 secondary outcome
Prostate cancer in BRCA carriers
Time frame: 2 years January 2016
Results and safety
This study is still under way. Results are not available in the source record yet.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 9 Sep 2025.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Danny J Vesprini, MD, MSc, FRCPC principal investigator
Sunnybrook Health Sciences Centre
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
A study testing MS3TMRI / TRUS Guided Biopsy in people with Prostate Cancer, run by Toronto Sunnybrook Regional Cancer Centre at 1 site in Canada.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 4 inclusion and 4 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: under way, not looking for participants, as of the sponsor's last update on 9 Sep 2025. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Canada. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
This study is still under way. Results are not available in the source record yet.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
Prostate MRI in BRCA carriers (time frame: 2 years (January 2016)). It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 9 Sep 2025.